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FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval.

There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.

In my opinion there two things going on here that I strongly feel are true.

1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.

I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.
> 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.

Where is the evidence that anyone has been harmed by these unapproved GLP1s? Until I see that I will assume the government is 100% in the wrong.
> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

Are we cutting off people's access to meds or do they just not want to pay what they cost?

> The rules and laws are there for a good reason.

"To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"

ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest.

And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.

Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.

I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez

> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc.

But it is all the rage when a pill can undo people's bad habits.

You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.
> The rules and laws are there for a good reason

Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.

The situation is basically this -

Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.

They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.

On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.

Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.

I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.

> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now.

Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing.

https://www.healthcompiler.com/cost-plus-drugs-vs-trumprx-ho...

> I highly recommend checking out the terms of trumprx.gov

The website is very good marketing for people who don't typically follow drug pricing. Here is more about why the only folks who will benefit are those without insurance—but those people will find better prices in several places, sometimes significantly better prices [1]. Further, it's likely that they're already finding those prices, since the website prices are no better than what you can get today outside fertility medication; and fertility medications are neither new, nor the most expensive part of that process.

This site has nothing to do with the effective subsidies that Americans provide to the world, and it will change nothing about that. The major thing that would help all Americans, negotiating for drug prices, has been neutered by the current administration. In fact, an executive order has specifically lengthened the amount of time that new drugs will be able to charge higher prices to Americans [2].

We should all be very careful in parsing news items that are not in our field of expertise.

1. https://www.nytimes.com/2026/02/05/health/trumprx-online-dru...

2. https://www.kff.org/medicare/the-effect-of-delaying-the-sele...

> unless you are at serious risk of diabetes

The US obesity rate is in the 40% range.

The most effective use of public funds would be to simply buy out the patent and give it out for free. It will save so much in future medical costs it's a no-brainer.

> hopefully that’s a net positive

It can't possibly be a net positive. The first pill costs $1B and subsequent ones costs 50 cents. Yes, the U.S. pays more, but the result can only be some combination of 1) other countries also paying more and 2) fewer new drugs.

>On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes.

I'm not understanding this part. If these drugs have solved obesity and the whole host of associated diseases, including the number one killer; heart disease, shouldn't the insurance companies be clambering over each other to cover these drugs and heavily encouraging their use considering the cost reduction on the overall health system.

And if the incentives are misaligned with insurance companies why are governments not handing out GLP-1s to anyone who asks?

> On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.

It's often up to the employer whether these meds are covered - many insurers just offer it as an option to check or not check.

That said, even at 3-6k/year, it wouldn't surprise me if these drugs were net savings to cover for a lot of patients due to their extremely positive effects as preventative care.

Novo will also sell you the auto-injector Wegovy directly starting at $199/month. And the pill starting at $149/month.
Good. Now we just need to cut out the doctors. No reason this medications shouldn't be over the counter.
The major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess.

India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses.

Welcome to a trade war.

After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)

I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.

What makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
I would silly things to hold onto a steady supply of pentadeca arginate. It has completely eliminated lingering effects of joint and ligament injury and has enabled me to exercise like a normal person. If you have the money it is very easy to acquire a year or twos worth from multiple sources.
It’s unfortunate that shutting these companies down will result in less people gaining access to the drug.

GLP-1’s might be the best thing to happen to medicine this decade - I personally want everyone who would benefit from it to have access.

Was my glucose under control without glp-1's? Yeah I could manage an a1c of 5.4-5.6 with metformin but I was still hovering near 300 lbs.

With glp-1's I'm down over 50 lbs, my a1c is a much more manageable around 4.0-4.5 and it makes it much easier to exercise and portion control is a huge benefit. Not to mention a buncha other things like triglicerides and blood pressure have come down due to exercise and eating better. it sucks i have to take it forever, but at the same time i feel a ton better physically, and if i loose 50 more lbs, and labs continue to show improvement, i can reduce the cocktail of other meds I'm on my doc says.

Cigna denied me at first until my doc appealed twice. Cigna wouldnt cover because i wasnt a full diabetic so wasnt on insulin. I would've had to pay close to $1k a month to take it otherwise. Thank goodness for a tenacious doctor!

It was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.

https://en.wikipedia.org/wiki/Government_patent_use_(United_...

There is zero need to “pirate” ozempic (semaglutide) as there are already US alternatives on the market (Tirzepatide) and about to be more (Retatrutide) that outperform all other medications in the class.

Just have insurers stop insuring ozempic/wegovy but have them insure mounjaro/zepbound and it’s a done deal. No need to even ban it.

The responds of Denmark and or worse the EU invalidating US patents in retaliation is rather dangerous.
Two can play at the game, and the EU was probably closer to starting it.

The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing.

At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes.

I'm quite convinced that:

(A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end.

(B) Denmark and most of EU and large parts of the world would never recognize an annexation.

(C) Congress in the US wouldn't recognize the annexation.

(D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off.

(E) Russia and China would be thrilled.

It was an allround shit show.

Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides.

But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?

This is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.
>blantatly skirting patent laws

Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.

The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.

If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to

>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.

> blantatly skirting patent laws

Can you please explain (TFA doesn't mention patent laws, just unregulated drugs)? For example, my understanding is that semaglutide is protected by patent in the US - I had assumed HIMS was including semaglutide in some of their formulations under an agreement with the patent holder, but I guess that's not correct?

Side note, I'm all for the true innovators being able to patent drugs (like semaglutide) that they put a lot of research dollars into, but seriously fuck all these additional "method of delivery" and "formulation" patents that are bullshit that just get added on later by the patent holder solely as a way to try to restrict the entry of generics into the market after the original patent expires.

Everyone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
I’m generally happy to see IP disrespected.
Yeah...so in India, the GLP patent owners went to court. however, it was deemed as patent expired in March 2026.

In anycase, India generally doesnt honor product patents for pharma. Right now, Indian pharma cos are court empowered to churn out GLP-1.

Everyone knows that we are gonna have 10$ GLP-1 before 2027 coming out of India.

It is wild that it took until 2026 for this to happen.

In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.

Ozempic lost its patent in Canada and a generic might be approved there soon.
For comedic relief on the GLP-1 issues, highly recommend "South Park: The End of Obesity" special.

https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity

Oh no next you're going to tell me they're coming after the gas station dick pills.
The real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
I thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
And India wins again!

There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.

Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].

Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.

[0] - https://www.reuters.com/business/healthcare-pharmaceuticals/...

[1] - https://www.reuters.com/business/healthcare-pharmaceuticals/...

[2] - https://www.whitehouse.gov/briefings-statements/2026/02/unit...

[3] - https://www.trump.com/residential-real-estate-portfolio/trum...

[4] - https://www.trump.com/residential-real-estate-portfolio/trum...

[5] - https://www.trump.com/residential-real-estate-portfolio/trum...

[6] - https://www.trump.com/residential-real-estate-portfolio/trum...

[7] - https://www.daines.senate.gov/2026/01/20/daines-travels-to-i...

[8] - https://governor.iowa.gov/press-release/2025-09-16/gov-reyno...

[9] - https://www.bloomberg.com/news/articles/2025-12-11/india-dra...

[10] - https://www.wsj.com/business/energy-oil/big-oil-is-offshorin...

[11] - https://www.bloomberg.com/news/features/2025-11-11/trump-s-h...

HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?